Validation of AI colonoscopy to improve adenoma detection rate: multicenter clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0009150

Enrollment

1000

Registered

2024-01-31

Start date

2023-10-24

Completion date

Unknown

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : (1) Control group: using general colonoscopy (2) Experimental group: Use of ‘endo Explorer’, an AI colonoscope (3) Random assignment - Randomly assign 1:1 control group and experiment

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: · Patients over 40 years old and under 80 years old · Those who can voluntarily consent to research · Patients receiving colonoscopy for the following reasons - Health screenings - Clinical symptoms - Follow-up examination after screening colonoscopy

Exclusion criteria

Exclusion criteria: · Persons for whom colonoscopy is absolutely contraindicated · Those with a history of colon surgery · Those whose pregnancy is confirmed or expected · Persons with confirmed or suspected intestinal obstruction · Those currently suffering from colon cancer or polyp syndrome · Patients with intestinal stricture (incomplete colonoscopy) · Patients with inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease, diverticulitis, infectious colitis) · Those receiving anticoagulant treatment (excluding antiplatelet drugs) · Those undergoing treatment or evaluation planned for another study

Design outcomes

Primary

Measure	Time frame
adenoma detection rate, ADR	—

Secondary

Measure	Time frame
mean number of adenomas per procedure, MAP;sessile serrated lesion detection rate, SDR;mean number of SSL per procedure, MSP	—

Countries

Korea, Republic of

Contacts

Public ContactBora Keum

Korea University Anam Hospital

borakeum@hanmail.net+82-2-920-6555

Outcome results